To understand mechanisms and devices employed to improve nasal airway patency, the anatomical structure should be understood. Nasal valves are anatomically divided into external and internal nasal valves. The external nasal valve is defined for each nostril laterally by the nasal alae with the underlying caudal border of the lower lateral cartilage, the columella at the base of the septum to the tip of the nose, the nasal floor, and medially by the septum. The nasalis muscles dilate the external nasal valve during inspiration. The opening to the external valve area is sometimes referred to as the nasal vestibule formed by walls as described. The internal nasal valve compromises the area bounded by the caudal border of the upper lateral cartilage, the septum, the head of the inferior turbinate and the pyriform aperture with tissues surrounding it.
Based on simplified laminar flow equations (referred to as the Poiseuille equation), a decrease in the radius of the nasal airway causes a 4-fold decrease in flow. Hence any reduction in the opening diameter of the nasal airway, especially in the vicinity of the external and/or internal valves, will significantly reduce inspiratory and expiratory air volume and flow rates. In addition this effect will be accentuated when a subject attempts to inspire rapidly which will reduce the air pressure inside the nasal cavity as compared to atmospheric pressure, and thereby cause more collapse of the affected nasal airway, i.e. Bernoulli effect. This effect becomes noticeable with vigorous exercise that is associated with rapid respiratory rates.
There are many causes of nasal obstruction. A common cause is idiopathic in which there is a reduction of cartilage and/or elastic tissue support needed to maintain patency of the valves both external and internal. In particular loss of support often involves the external valves and/or prolapse of the nasal tip of the nose. As aging occurs this effect can become more noticeable. Other causes of nasal obstruction include septal deviation; turbinate hypertrophy from allergy and/or rebound swelling from overuse of vasoconstrictor nasal sprays; trauma-induced; iatrogenic post-rhinoplasty; foreign bodies; neoplasm and polyps and from other less common medical conditions. A health care provider can evaluate the cause of nasal obstruction visually with rhinoscopes; CT scan; MRI; measurement of air flow; and by a simple test of valve patency, commonly referred to as the Cottle test. In this test the subject is instructed to gently obstruct one nostril at a time with a finger to determine subjective reduction of inspiratory nasal air flow involving the contralateral nostril. Then the subject is instructed to place one or two fingers on the lower side of the contralateral nostril at the nasal-facial angle, and stretch the skin toward the ipsilateral ear. The procedure is repeated for the other nostril. If the nasal valve (external and/or internal) is partially or completely obstructing air flow, stretching the skin laterally will pull on the underlying tissues attached to the nasal valves and/or vestibules and open them to improve air flow/volume into that tested side of the nasal cavity. The Cottle test is considered a subjective diagnostic test for the presence of nasal valve obstruction. It is sometimes used by plastic or ENT surgeons to determine if a subject might be a candidate for a rhinoplastic procedure to improve nasal obstruction and/or as a post-operative test to validate improvement in nasal airway obstruction. Although not specifically described by the Cottle effect, a similar stretching of skin posterior of the lateral canthi in a lateral and somewhat superior vector can also effect nasal valve/vestibule patency. This effect is discussed in the description of the invention herein as it is applied to swim goggles.
There are many marketed devices available to improve nasal airway patency in subjects with obstruction from external/internal valves. The purpose of these devices is to ease airway flow during sleep or exercise and to reduce snoring. In some situations, nasal obstruction may force a subject to breathe through the mouth, which will exacerbate snoring due to oral-pharyngeal tissue vibrations. In some subjects with sleep apnea, severely impaired nasal obstruction with or without associated mouth breathing, can exacerbate severity of sleep apnea and also make it more difficult to correct sleep apnea with nasal or full face continuous positive airway pressure (CPAP) masks.
Marketed nasal dilator devices fall into three categories. The first are external devices associated with adhesive tape applied to the nose (e.g. U.S. Pat. No. 5,476,091; U.S. Pat. No. 5,806,525), and/or to the nasal alae (e.g. U.S. Publication No. 2007/0255309; U.S. Pat. No. 8,047,201), and/or to the tip of the nose (e.g. U.S. Pat. No. 5,669,377; U.S. Publication No. 2011/0106140). These nasal devices with adhesives contain resilient spring or biasing mean(s), that when applied to the various locations of the nose, cause the attached skin and underlying tissue(s) to open the nasal valves and thereby improve nasal air flow in the subject. These tapes come in a variety of shapes, can be placed on various locations of the nose and/or face, contain a variety of spring mechanisms and use different kinds of adhesives. A limitation of such tapes are they are designed to be used one time and disposed and cannot be relocated easily for comfort or to adjust to improve nasal valve opening because adhesive tape loses its ability to adhere if removed and reattached. Hence they are expensive, environmentally objectionable, cannot be relocated easily, are not reusable, and on a personal level subjects often stop using them because they peel off under oily or sweaty skin, thereby defeating their purpose to improve nasal air flow during sleep or with physical activities. They can cause discomfort when peeled off, and individuals who use facial lotions, cannot achieve good adherence to their nose and/or face with these adhesives. Additionally subjects using these tapes may notice transient swelling of the nasal alae and vestibules, which is unsightly and may be caused by venous pooling and reduced venous outflow from the nasal tissues while wearing the tapes.
A newly marketed device (U.S. Pat. No. 8,240,309; U.S. Pat. No. 8,302,607) called Theravent® uses a tape to occlude both nostrils. The tape includes a micro-valve technology that inhibits expiration more than inspiration to create expiratory positive airway pressure within the nasal-pulmonary respiratory tract. The increase in expiratory resistance can retain air volume that expands the diameters of the nasal-respiratory tract and thereby improve nasal airflow during inspiration. It is costly as a disposable, can cause whistling through one way valves during respiration, may not work if the air pressure seal is broken by mouth breathing and users express discomfort noticing that before falling asleep they cannot breathe normally because of increased expiratory resistance. They also cannot be relocated and reattached easily as adhesive tape loses its adherent ability once removed and then reattached. U.S. Pat. No. 6,006,746 shows adhesive pads with a resilient nasal dilator member to attach to eyeglasses. The adhesive attaching means interfere in adjustment of the eyeglass for optimizing visual acuity once the adhesive attachment of the nasal dilator is in place. Also the adhesive nasal dilator can only be used one time.
U.S. Pat. No. 8,051,850 shows a nasal dilator device with attaching means for contact pads that use adhesives or friction pressure to keep the contact pads from pulling off a user's face. As will be best understood with the description of the benefits of the present invention, the disadvantages of structure FIG. 5 in U.S. Pat. No. 8,051,850 for a nasal dilator are: (1) it employs a completely circumferential elastic head band that can be displaced by user head movement and thus makes it difficult to maintain forces for nasal dilation to either or both sides of user's nose; (2) it does not include a mound that provides added moments of forces to enhance opening nasal passages (3) it does not include a holding means for mound(s) to maintain mound positioning; and (4) it does not include means to adjust and/or relocate and/or reuse contact pads to same or different location(s) in relation to user's nose and/or face and/or head as needed to improve nasal patency and/or patient comfort. Instead it uses contact pads that are held on the user's face by adhesives or friction that minimize easy repositioning if needed. The adhesives lose their attaching means once removed and repositioned, and both adhesives and friction means cause difficulty maintaining positioning when an active exerciser sweats or experiences facial distortions during exercise which will lessen adherence to a user's face. In an iteration of U.S. Pat. No. 8,051,850, FIGS. 5 and 6, show adhesive contact pads for a nasal dilator with a strap over the resilient nasal dilating spring that will vector posteriorly onto the user's nose and reduce the objective of achieving maximum nasal valve and/or vestibule patency. In U.S. Pat. No. 8,051,850, FIG. 8 shows an embodiment of a nasal dilator for a CPAP mask with laterally pulling forces using adhesive or friction contact pads held by the posterior vectored force of CPAP mask head retainer straps. This embodiment has limitations in repositioning, adjustment or reuse of the contact points and doesn't include a mound(s) for enhancing moment of force for nasal dilation nor a means to hold said mound(s). FIG. 9 in same patent for CPAP masks, applies a nasal dilator with an adhesive with previously described inherent disadvantage, all integrated into a CPAP mask and is also void of a mound element to enhance nasal dilation. As a result, there remains numerous commercial disadvantages with these various devices employing tape, friction holding means or other adhesive elements.
The second category of nasal dilators (e.g. U.S. Pat. No. 6,863,066; U.S. Pat. No. 6,004,342; U.S. Pat. No. 7,563,271) are spring-like nasal dilators that are inserted inside the nostrils to expand the volume of air space inside the vestibules. These devices are made of metal or plastic, and have a resilient spring mechanism that expand the vestibules in many directions, particularly anteriorly and laterally. Subjects are instructed to leave them in situ inside the nasal cavities during sleep and/or exercise. The problems and limitations with these devices include: (1) they behave as a foreign body inside the nose and may cause discomfort, itching, and in some subjects, reflex sneezing. There are also case reports in the medical literature involving these devices being displaced unknowingly inside the nose of users and creating foreign body-induced inflammation; (2) they can cause pressure induced erosions and epistaxis; (3) they have the potential to irritate and enhance neuro-reflex induction of nasal mucosal swelling and rhinorrhea and thereby increase nasal obstruction; (4) they should be cleaned optimally each day before reinserting them inside the subject's nose to prevent bacterial contamination and infection inside the nostrils; (5) wearing them especially when turning over in bed during sleep or during exercise can cause them to fall out of the nose and (6) additionally subjects using these devices may notice post-use swelling of the nasal alae, which although transient, is unsightly and may be caused by venous pooling from reduced nasal venous outflow while wearing the devices.
A third category uses a head band or mask to enhance nasal valve opening and combines adhesive or non-adhesive attaching means for nasal dilator function. For example, U.S. Pat. No. 8,459,254 describes a device using an adhesive to attach an elastic band to each side of the nose. The elastic band wraps over the ears circumferentially around the back of the head to permit tightening and attaching the device to the user's face and head. By stretching the head retainer strap laterally on the user's face, the attachment sites of the skin pull open the nasal valves per the Cottle effect. It employs a completely circumferential elastic head band that can be displaced by user head movement and thus makes it difficult to maintain forces for nasal dilation to either or both sides of user's nose. The adhesive could be pulled off the skin if the stretch pressure exceeds the force of adhesive attachment to the skin. Moreover, some users cannot tolerate adhesives because they cause contact skin irritation and users who apply facial creams or lotions may have difficulty keeping adhesive tape in place. There is also specific mention that the invention avoids coverage over a subject's nose. Once the adhesive is applied, then adjusting the mask for comfort or to improve opening the valves becomes difficult, as most adhesives curl up or lose their adherence ability when they are pulled off and reapplied. In essence, this category of devices does not have an easy reversible adjustable, repositionable or reusable means to obtain an optimal comfortable lateral pull to open the nasal valves nor can it be reused without changing the adhesives. Moreover because it employs a circumferential elastic band and not a rigid or semi-rigid housing, the forces distributed to either or both sides of the user's nose for nasal dilation can be dissipated by displacement of the head band with user head movement. This nasal valve opening device can attach to eye glasses directly to the device using adhesive means to attach to a user's face that doesn't permit adjustment, and as such, it is apparent the device must remain permanently attached to the skin of the user which would otherwise preclude visual optimization for the user. Other similar devices (e.g. U.S. Publication No. 2007/0028917; U.S. Publication No. 2001/0023695; U.S. Publication No. 2009/0025715; and U.S. Pat. No. 6,860,263) also utilize adhesive tape means for attachment on each side of a user's face to open nasal valves.
U.S. Pat. No. 6,336,456 and U.S. Publication No. 2012/0285468 describe a surgical and ventilation mask respectively, both worn about the nose and face and tied about ears and head. Both include a nasal dilator mechanism comprised of adhesives strategically located inside the masks. U.S. Pat. No. 6,336,456 describes the adhesives both on the inside of the mask and on opposing sides of the user's nose. When the adhesive tapes on the user's skin and inside the mask attach to each other, the mask has an inherent resilient spring which forces the mask to return to its original configuration, and thereby cause nasal valves to open when the skin overlying the user's nose moves away, anteriorly and laterally. The adhesive resilient spring may improve external nasal valve patency but it does not provide for an adequate lateral vector pull to open the internal and external nasal valves. The described nasal dilator of U.S. Pat. No. 6,336,456 is in essence a hybrid of the external type of nasal dilator previously described, but with a mask containing the resilient member rather than having the resilient member located within the adhesive parts. Therefore, it has the same limitations using adhesive tape as it cannot be reused or relocated easily and/or adjusted for comfort to improve nasal airway function. In addition, the mask disclosed in U.S. Pat. No. 6,336,456 covers most of the face, including mouth and nose, and likely comes in contact with the user's nose, all part of it functioning as a surgical mask.
U.S. Publication No. 2012/0285468 shows a ventilation mask containing an adhesive material to open the nasal valves. U.S. Publication No. 2012/0160240 describes a mask for a subject to wear to occlude light that may interfere with sleep and improve nasal breathing by decreasing nasal valve obstruction. These devices do not include an adhesive and instead include an elastic tightening means that encircles the user's head. The dilator function occurs by applying pressure directly onto the nose to cause the nostrils to expand. Its disadvantages are: (1) it applies inward posterior forces onto the nose and doesn't take advantage of the Cottle effect to maximize nasal vestibular and nasal valve patency; (2) it can reduce nasal vestibule volume by applying direct posterior vector pressure on the nose; and (3) the overall pressure applied to the nose creates user discomfort especially during sleep.
U.S. Publication No. 2011/0265802 shows a device worn to prevent mouth opening during sleep to minimize snoring. The forces apply a tightening vector above the upper lip and below the lower lip and under the chin to maintain closure of the mouth. These forces oppose the lateralizing forces needed to open the nasal valves and the device does not include an element to cross over and not contact the nose to optimize lateral forces.
All publications and patent applications in this specification are indicative of the level of ordinary skill in the art to which this invention pertains. All publications and patent applications are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated as incorporated by reference.
These aforementioned exemplary devices represent the commercially available options other than rhinoplasty; implant insertion both permanent and temporary to support and maintain internal valve patency; injection of a biomaterial to support the internal valve; nasal curettage using mechanical and/or a variety of electro-magnetic energy to improve nasal airway patency involving the nasal valves. Rhinoplasty may actually cause nasal airway obstruction when cartilage and other supporting structures are altered or resected as part of the procedure. It is estimated that ten percent of post-rhinoplasty subjects experience nasal obstruction.
Advantages of nasal breathing are well known as nasal breathing filters inspired air, humidifies dry air and warms cold air. Mouth breathing is undesirable during sleep and exercise, as it causes uncomfortable mouth dryness, dehydration and increases the likelihood of dental caries. There are also training devices, such as the Frolov breathing device, and educational web sites (e.g. www.normalbreathing.com) devoted to teaching how to improve nasal breathing over mouth breathing. Several claims are made regarding the advantage of nasal breathing versus mouth breathing. One claim states that nasal breathing retains more carbon dioxide in the upper respiratory tract which increases alveolar CO2 concentration on inspiration, thereby improving alveolar capillary vasodilation from retained CO2 and ultimately enhancing oxygen exchange into the circulation. Learning to breathe through one's nose requires constant conscious training which is not applicable to sleep and hence would not likely be effective for most individuals.
Hence there is a need in the art for devices and methods of use thereof that maintains and improve patency of the nasal valves and/or nasal vestibules without all the inherent risks and objections associated with existing nasal dilators. The present invention for various applications overcome these risks and objections as disclosed herein. The Detailed Description of the applications of the invention, utilize the Cottle effect by applying external forces around the user's nose, and/or face and/or head that cause underlying intricate anatomical attachments to the nose to open the nasal passages.
It is therefore a primary object, feature and/or advantage of the present invention to overcome deficiencies in the art of nasal dilation.
It is another objective, feature and/or advantage of the present invention to provide a nasal dilator device and method of use that aids in opening nasal valves, and/or nasal vestibules, can be adjusted, relocated, reused and retained on the user without easily falling off during sleep or during physical activity and exercise.
It is another objective, feature and/or advantage of the present invention to provide a nasal dilator device and method of use that opens nasal valves and/or nasal vestibules by including a housing or shell with a bridge located at any single or combination of locations such as over, above or below the nose, that apply forces on each side of the nose to improve nasal patency.
It is another objective, feature and/or advantage of the present invention to provide a nasal dilator device and method of use that can be worn for many applications such as for: sleep alone; sleep with a CPAP mask; snow related sports, motor biking related and contact or non-contact sports; for tactical military users; and swimming with goggles or with swim caps.
It is another objective, feature and/or advantage of the present invention to provide a nasal dilator device and method of use that provides comfort for the user both during sleep and/or during physical activities.
It is another objective, feature and/or advantage of the present invention to provide a nasal dilator device and method of use that can be customizable by altering dimensions, shapes, and material composition, so that users with different facial and head shapes and/or nasal dimensions can wear the device and still accomplish the same function to open the nasal valves and/or vestibules.
It is another objective, feature and/or advantage of the present invention to provide a nasal dilator device and method of use to improve nasal passage patency and reduce mouth breathing.
Other objects, advantages and features of the present invention will become apparent from the following specification taken in conjunction with the accompanying drawings.